Our Opinions relate primarily to proposals for legislation and are addressed to the EU legislator (the European Parliament, the Council and the European Commission), with the aim of flagging main data protection concerns together with our recommendations.
These Opinions are issued in response to requests by the Commission, which is legally obliged to seek our guidance on any legislative proposal, or draft implementing or delegated acts, as well as recommendations and proposals to the Council in the context of international agreements according to Article 42(1) of Regulation (EU) 2018/1725 where there is an impact on the protection of personal data. We also issue own-initiative opinions as part of our role as advisor on all matters relating to the processing of personal data.
Opinion on the Commission proposal for a Regulation amending Council Regulation (EC) No 1346/2000 on insolvency proceedings
Opinion on the Communication from the Commission on 'eHealth Action Plan 2012-2020 - Innovative healthcare for the 21st century'
Opinion on the Commission proposals for a Regulation on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and a Regulation on in vitro diagnostic medical devices
Opinion on the Proposal for a Regulation amending Regulation (EC) No 273/2004 on drug precursors and the Proposal for a Regulation amending Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors
Opinion on the Commission proposal for a Regulation on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC